The U.S. Food and Drug Administration has approved Siliq (brodalumab) as a treatment for adults with moderate-to-severe plaque psoriasis. Read More »

The first new drug approved specifically to treat amyotrophic lateral sclerosis (ALS), commonly referred to a Lou Gehrig’s Disease, in over two decades was approved in less than a year, thanks in large part to the FDA working in conjunction with Mitsubishi Tanabe Pharma Corp. and the ALS Association. Read More »

The Food and Drug Administration has approved Genentech's Lucentis as a treatment for all forms of diabetic retinopathy, the leading cause of blindness among working age adults in the country. Read More »

EMD Serono has received Food and Drug Administration approval of BAVENCIO (avelumab) as a treatment for locally advanced or metastatic urothelial carcinoma. Read More »

Pharmacy benefit managers should be praised for helping to keep down the cost of prescription drugs, rather than attacked by Congress and others, according to one health policy adviser. Read More »

Mylan's Biologics License Application for MYL-1401H, a proposed biosimilar to Neulasta (pegfilgrastim), has been accepted by the U.S. Food and Drug Administration. Read More »

AbbVie, a global biopharmaceutical company, recently announced its Viekirax + Exviera eight-week treatment program has been granted a positive opinion by the European Committee for Medicinal Products for Human Use of the European Medicines Agency. Read More »

The European Commission has adopted a decision to change the Repatha (evolocumab) marketing authorization, approving a new single-dose delivery option. Read More »

Teva Pharmaceutical Industries Ltd. has launched AirDuo RespiClick, an inhalation powder for the treatment of asthma in patients 12 and older. Read More »

Shire PLC's Natpar, an adjunctive treatment for adult patients with chronic hypoparathyroidism, was reviewed positively by the Committee for Medicinal Products for Human Use of the European Medicines Agency. Read More »

The Pharmaceutical Care Management Association (PCMA) has recommended that the next Food and Drug Administration (FDA) director adopt five specific strategies to encourage pharmaceutical pricing competition based on results of its recently commissioned report. Read More »

EMD Serono, the biopharmaceutical business of Merck KGaA and Pfizer Inc., recently announced that the Biologics License Application (BLA) for their avelumab drug was accepted for Priority Review by the U.S. Food and Drug Administration (FDA). Read More »

Bracco Diagnostics, the U.S. subsidiary of Bracco Imaging, has had its Varibar Pudding product approved by the U.S. Food and Drug Administration. Read More »

The American Society of Health-System Professionals recently announced that the United States updated the Common Rule, a federal regulation that supports research involving human subjects. Read More »

ALK's house dust mite (HDM) sublingual allergy immunotherapy tablet has been approved in 12 European countries, to include availability for adolescent patients. Read More »

The U.S. Food and Drug Administration has approved two applications for treatments of hepatitis C in children. Read More »

Ingrezza (valbenazine) has been approved by the Food and Drug Administration for the treatment of tardive dyskinesia in adults. Read More »

AbbVie shared the successful results of its Phase IIb clinical trial on elagolix on patients suffering from heavy menstrual bleeding due to fibroids last week. Read More »

Tocagen Inc. recently announced that its Toca 511 & Toca FC drug received Breakthrough Therapy Designation from the U.S. Food and Drug Administration. Read More »

Sanofi and Regeneron Pharmaceuticals Inc.'s Dupixent injection has been approved by the U.S. Food and Drug Administration (FDA) for use treating adults with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies. Read More »